Trial | NCT02323477  Report issue

Title

Human Umbilical Cord Stroma MSC in Myocardial Infarction
The Efficacy and Safety Assessment of Human Umbilical Cord Stroma-derived Multipotent Stromal Cells in Myocardial Infarction; a Phase 1/2 Clinical Trial (HUC-HEART Study)

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    46
The purpose of this phase 1/2 clinical trial is to evaluate the efficacy and safety of allogeneic human umbilical cordstroma derived multipotent stem cells (hUCS-MSCs) in myocardial infarction (MI). All subjects will be taken into the bypass coronary surgery prior to the cell administration. This 2-year study comprise three independent groups, where the first group (n=20) will take no cells, second group will take autologous BM-MNCs (n=20), and third group (n=39) will be receiving allogeneic hUCS-MSCs. In all transplantations cells will be administered to the approximately 10 peri-infarct areas at one time. The infarct zone will be determined by the MR, SPECT and PET imaging. Only male subjects between 30-80 years of age. The efficiency of the therapy will be evaluated according to the parameters measured by MR, SPECT, and Echocardiography. All subject were taken into those measurements prior and 6, 12, 18 and 24 months after the operation.
Study Started
Feb 02
2015
Primary Completion
Sep 30
2018
Study Completion
Dec 30
2018
Last Update
Jul 10
2020

Biological stem cell transplantation

Human allogeneic umbilical cord MSC or autologous BM-MNC transplantation

Allogeneic umbilical cord MSC group Experimental

Allogeneic human umbilical cord MSCs will be transplanted to 39 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF<%45)

Autologous bone marrow-derived MNC group Active Comparator

Autologous bone marrow-derived MNCs will be transplanted to 20 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF<%45)

Control group No Intervention

20 male patients (age 30-80) undergoing CABG in chronic ischemic cardiomyopathy (EF<%45) whom will not received any further transplantation

Criteria 

Inclusion Criteria:

Ischemic hearth disease who will experience CABG
%25<EF<%45
NYHA class II-IV patients
hemodynamically stable

Exclusion Criteria:

Patient's in approval
Acute cardiac decompensation
Acute myocardial infarction
Congenital heart disease
Additional surgical heart disease other than coronary artery disease
Malign arrhythmia
All malignancies
HbA1c level >%10 (86 mmol/mol) type II diabetes mellitus
Severe liver dysfunction
Severe COPD
Coagulopathy
Immunosuppressive treatment
Acute hepatitis, hepatitis B, C and HIV infection
Chronic liver and renal failure
Collagen tissue disease
Stroke
TB
Hematological diseases
Socially and mentally disabilities
No Results Posted